Quality Assurance Program Manager

Company: DHL Supply Chain
Location: Livermore
Posted on: February 22, 2021

Job Description:

Quality Assurance Program Manager
Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers . Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liason with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support global and cross-sector Quality and Regulatory initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems.
- Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.- Oversee the licenses, permits, and registrations process.- Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management- Ensure that systems and equipment are validated (if applicable) and change control processes maintained- Hire, train, and develop quality associates.- Monitor the training and development of site associates to ensure compliance to processes and regulations.- Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops- Review and provide recommendations on regulatory, customer and 3rd party audits.- Review and identify trends within the quality assurance metrics for the organization.- Primary customer contact for QA related issues/initiatives as needed.- Develop, distribute and maintain regular management reports- Manage site suppliers and prepare, receive, and act on audits- Provide Business Development support and represent DHL in customer events and meetings as required
Required Education and Experience- Bachelor's degree in a related field or 5-7 years relevant work experience- Graduate's degree in related field- Certification related to quality control (RAC, Six-Sigma, etc.)- 5+ years of relevant experience in a regulated environment such as FDA, Health Canada, etc. - 3-5 years of supervisory or management experience (preferably supervising/managing a quality system in a complex/matrix organization)- Participation in a successful standards organization registration in a complex environment- Logistics industry experience- Project management and problem solving skills- Knowledge of regulations such as FDA, GxPs, ATF, DEA etc. - Administrator of training in compliance to regulated standards

Keywords: DHL Supply Chain, Livermore , Quality Assurance Program Manager, Executive , Livermore, California